Objective: To investigate the efficacy and safety of daratumumab in relapsed and refractory multiple myeloma (RRMM). Methods: The efficacy and adverse events (AEs) of daratumumab based regimens were retrospectively analyzed in 37 patients with RRMM from Peking University People's Hospital, Beijing Hospital and Fu Xing Hospital affiliated to Capital Medical University in China. The deadline for inclusion was December, 2019. Results: Among the 37 patients, 35 patients were available for response evaluation. The overall response rate (ORR) was 68.6%, which was better in patients receiving 16 mg/kg daratumumab than in those with fixed doses of 800 mg daratumumab [ORR: 78.3%(18/23) vs. 40.0%(4/10)]. The percentage of infusion related reactions of daratumumab was 27.0%(10/37). The most common hematological AEs were lymphocytopenia and thrombocytopenia, with the incidences of grade 3 or more severe 59.5%(22/37) and 43.2%(16/37) respectively. Pulmonary infections(37.8%, 14/37) were the most common non-hematological AEs. One patient with positive hepatitis B surface antigen (HBsAg) and two patients dependent on dialysis were safely treated with daratumumab. Conclusion: Daratumumab is highly effective in relapsed and refractory multiple myeloma. Adverse reactions are mild and well tolerable.
目的： 探讨达雷妥尤单抗治疗复发难治性多发性骨髓瘤（MM）的安全性及有效性。 方法： 回顾性分析北京大学人民医院、北京医院、首都医科大学附属复兴医院截至2019年12月的37例复发难治性MM患者使用以达雷妥尤单抗为主的治疗后的疗效及不良反应。 结果： 37例复发难治性MM患者中35例可进行疗效评估，总体缓解率（ORR）为68.6%，16 mg/kg剂量组的疗效优于800 mg固定剂量组[ORR：78.3%（18/23）比40.0%（4/10）]。输注相关的不良反应发生率为27.0%（10/37）；常见的血液学不良反应为淋巴细胞减少及血小板减少[3级及以上的发生率分别为59.5%（22/37）和43.2%（16/37）]；常见的非血液学不良反应是肺部感染[37.8%（14/37）]。达雷妥尤单抗在1例乙型肝炎表面抗原阳性及2例透析患者中使用安全。 结论： 达雷妥尤单抗治疗复发难治性MM的总体缓解率高，不良反应轻微，耐受性好。.
Keywords: Daratumumab; Multiple myeloma; Refractory; Relapsed.